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dc.contributor.authorCamidge, D. R.
dc.contributor.authorKim, H. R.
dc.contributor.authorAhn, M. J.
dc.contributor.authorYang, J. C. H.
dc.contributor.authorHan, J. Y.
dc.contributor.authorHochmair, M. J.
dc.contributor.authorLee, K. H.
dc.contributor.authorDelmonte, A.
dc.contributor.authorGarcia, Campelo, MR
dc.contributor.authorKim, D. W.
dc.contributor.authorGriesinger, F.
dc.contributor.authorFelip, E.
dc.contributor.authorCalifano, Raffaele
dc.contributor.authorSpira, A.
dc.contributor.authorGettinger, S. N.
dc.contributor.authorTiseo, M.
dc.contributor.authorLin, H. M.
dc.contributor.authorGupta, N.
dc.contributor.authorHanley, M. J.
dc.contributor.authorNi, Q.
dc.contributor.authorZhang, P.
dc.contributor.authorPopat, S.
dc.date.accessioned2020-09-16T11:57:53Z
dc.date.available2020-09-16T11:57:53Z
dc.date.issued2020en
dc.identifier.citationCamidge DR, Kim HR, Ahn M-J, Yang JCH, Han J-Y, Hochmair MJ, et al. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor�Naive ALK-Positive Non�Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. Journal of Clinical Oncology. 2020:JCO.20.00505.en
dc.identifier.pmid32780660en
dc.identifier.doi10.1200/jco.20.00505en
dc.identifier.urihttp://hdl.handle.net/10541/623229
dc.description.abstractPurpose: Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer (NSCLC) at first interim analysis (99 events; median brigatinib follow-up, 11.0 months) in the open-label, phase III ALTA-1L trial (ClinicalTrials.gov identifier: NCT02737501). We report results of the second prespecified interim analysis (150 events). Methods: Patients with ALK inhibitor-naive advanced ALK-positive NSCLC were randomly assigned 1:1 to brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was PFS as assessed by blinded independent review committee (BIRC). Investigator-assessed efficacy, blood samples for pharmacokinetic assessments, and patient-reported outcomes were also collected. Results: Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138). With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank P < .0001; median, 24.0 v 11.0 months). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31 to 0.61; median, 29.4 v 9.2 months). No new safety concerns emerged. Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049). Brigatinib daily area under the plasma concentration-time curve was not a predictor of PFS (HR, 1.005 [95% CI, 0.98 to 1.031]; P = .69). Conclusion: Brigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1200/jco.20.00505en
dc.titleBrigatinib versus crizotinib in advanced alk inhibitor-naive alk-positive non-small cell lung cancer: second interim analysis of the phase III ALTA-1L Trialen
dc.typeArticleen
dc.contributor.departmentUniversity of Colorado Cancer Center, Aurora, CO.en
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.noteen]
refterms.dateFOA2020-09-16T13:06:28Z


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